Major Breast Cancer Prevention Trial Seeks Minority Women During

National Minority Cancer Awareness Week Five Sites in Washington and Oregon Hope to Recruit More Women To the Study of Tamoxifen and Raloxifene, known as STAR

Seattle - Five sites for the Study of Tamoxifen and Raloxifene (STAR) hope to recruit more women during National Minority Cancer Awareness week. The sites are part of the Fred Hutchinson Cancer Research Center's Puget Sound Oncology Consortium (PSOC), and include sites in Bremerton, Spokane, Bend, Ore., Bellingham and Seattle.

To date 79 women locally have been recruited for the Hutchinson Center-coordinated study, ranking fifth in recruitment nationwide. The recruitment goal for the Pacific Norwest region is 300 women. Although the Hutchinson Center study is on target for recruitment in overall numbers, it is well below the goal for racial and ethnic minority participation.

"We are excited about the number of women who have volunteered to participate," says Joelle Machia, program coordinator and clinical research nurse. "Yet, our work is just beginning, and to better understand the preventive effects of these drugs and to achieve success many more women need to be enrolled to the study, both locally and nationally."

According to Norman Wolmark, M.D., chairman of the National Surgical and Bowel Project (NSABP) a major weakness in the present clinical trial system is that few women and men from racial and ethnic minority groups choose to participate in studies.

The NSABP has a special effort underway to educate minority women not only about STAR but also about breast cancer. SCOPE, the STAR Community Outreach Program for Education, seeks to address the myths that abound in the minority community about breast cancer; about who is at risk for the disease; and about why more minority women need to participate in clinical trials. Community outreach coordinators (COCs) now involved in SCOPE represent women from the African-American, Native American, and Hispanic communities in major cities in North America such as Philadelphia, Penn; Dallas Tex; Chicago, Ill; Tulsa, Okla; Houston, Tex; Phoenix, Ariz; Greenville, S Car; Washington, DC; and Winston-Salem, N Car. Efforts are underway to expand this program to the Asian-American community and other cities.

Bertie Ford, RN, MS, OCN, the chairman of the NSABP's Minority Representation Committee, says, "If we want answers about health problems that pertain to African-American women, then we must get involved in research studies. Much of the research done on women's health problems has not involved many black women. Researchers are forced to assume that findings from those studies apply to all populations of women. I encourage all minority women to take part in clinical trials so that we can discover whether these assumptions are true."

"The overall accrual to STAR is on track, and currently four percent of the women enrolled in STAR are from a racial or ethnic minority group," says Worta McCaskill-Stevens, M.D., NCI program director for STAR, although 12 percent of the women whose breast cancer risk has been evaluated represent a minority population."

STAR is currently seeking women who are postmenopausal, at least age 35, and have an increased risk of breast cancer as determined by their age, family history of breast cancer, personal medical history, age at first menstrual period, and age at first live birth. Once a woman chooses to participate, she will be randomly assigned to receive either 20 mg tamoxifen or 60 mg raloxifene daily for five years and will have regular follow-up examinations, including mammograms and gynecologic exams.

Over 500 centers across the United States, Puerto Rico, and Canada are participating in STAR, making the trial accessible to most women in those countries. The exams required in STAR are customary for women at high risk of developing breast cancer and are charged to a woman's insurance. However, researchers say that the lack of health insurance should not deter a woman from joining the trial.

The maker of tamoxifen, AstraZeneca Pharmaceuticals, Wilmington, Del. and the maker of raloxifene, Eli Lilly and Company, Indianapolis, Ind., are providing their drugs for the trial without charge.

The NSABP, a non-profit, clinical trials cooperative group is supported primarily by grants from the National Cancer Institute. For more than 40 years, the NSABP has successfully conducted large-scale, randomized clinical trials in colorectal and breast cancer that have altered and improved the standard of care for men and women with these diseases.

The Fred Hutchinson Cancer Research Center is an independent, non-profit research institution dedicated to the development and advancement of biomedical technology to eliminate cancer and other potentially fatal diseases. Recognized internationally for its pioneering work in bone marrow transplantation, the Center has four scientific divisions collaborating to form a unique environment for conducting basic and applied science. One of 35 National Cancer Institute-designated comprehensive cancer centers in the country, it is the only one in the Northwest. For more information, visit the Center's web site at http://www.fhcrc.org.

For more information about STAR contact the PSOC Coordinating Site at (206) 667- 6544 or visit NSABP's Web site at http://www.nsabp.pitt.edu or NCI's clinical trials Web site at http://cancertrials.nci.nih.gov.

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The Fred Hutchinson Cancer Research Center is an independent, nonprofit research institution dedicated to the development and advancement of biomedical technology to eliminate cancer and other potentially fatal diseases. Recognized internationally for its pioneering work in bone-marrow transplantation, the Center's four scientific divisions collaborate to form a unique environment for conducting basic and applied science. The Hutchinson Center is the only National Cancer Institute-designated comprehensive cancer center in the Pacific Northwest. For more information, visit the Center's Web site at <www.fhcrc.org>.

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